"The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV"...
[Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant] Suspension for Intramuscular Injection
CERVARIX [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant] is a non-infectious recombinant, AS04-adjuvanted vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid, of oncogenic HPV types 16 and 18. The L1 proteins are produced in separate bioreactors using the recombinant Baculovirus expression vector system in a serum-free culture media composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Following replication of the L1 encoding recombinant Baculovirus in Trichoplusia ni insect cells, the L1 protein accumulates in the cytoplasm of the cells. The L1 proteins are released by cell disruption and purified by a series of chromatographic and filtration methods. Assembly of the L1 proteins into virus-like particles (VLPs) occurs at the end of the purification process. The purified, non-infectious VLPs are then adsorbed on to aluminum (as hydroxide salt). The adjuvant system, AS04, is composed of 3-O-desacyl-4'-monophosphoryl lipid A (MPL) adsorbed on to aluminum (as hydroxide salt).
CERVARIX is prepared by combining the adsorbed VLPs of each HPV type together with the AS04 adjuvant system in sodium chloride, sodium dihydrogen phosphate dihydrate, and Water for Injection.
CERVARIX is a sterile suspension for intramuscular injection. Each 0.5-mL dose is formulated to contain 20 mcg of HPV type 16 L1 protein, 20 mcg of HPV type 18 L1 protein, 50 mcg of the 3-O-desacyl-4'-monophosphoryl lipid A (MPL), and 0.5 mg of aluminum hydroxide. Each dose also contains 4.4 mg of sodium chloride and 0.624 mg of sodium dihydrogen phosphate dihydrate. Each dose may also contain residual amounts of insect cell and viral protein ( < 40 ng) and bacterial cell protein ( < 150 ng) from the manufacturing process. CERVARIX does not contain a preservative.
The tip caps may contain natural rubber latex; the plungers are not made with natural rubber latex.
What are the possible side effects of human papillomavirus vaccine (Cervarix)?
You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.
Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
You may feel faint after receiving this...
What are the precautions when taking human papillomavirus bivalent vaccine (Cervarix)?
Before receiving this vaccine, tell your health care professional if you are allergic to it; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the packaging of some products), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before receiving this vaccination, tell your health care professional your medical history, especially of: immune system problems (such as HIV infection), bleeding disorders (such as hemophilia, thrombocytopenia), current fever/illness.
This vaccine is not recommended for use during pregnancy. Consult your doctor for more details.
It is unknown if this vaccine passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 10/19/2015
This monograph has been modified to include the generic and brand name in many instances.
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